Surgeons at Carolinas Medical Center and the Cleveland Clinic are leading a study that is part of a national effort to bring new therapies to the United States first, instead of waiting until other countries have tried them in humans.
Dr. Frank Arko of the Sanger Heart & Vascular Institute is collaborating with Dr. Eric Roselli of Cleveland to enroll seven patients in the trial of a new device for treating aortic aneurysms in the chest.
The device, called a branched stent graft, is implanted into the aorta, to repair the aneurysm, in a procedure that is less invasive than traditional surgery.
The graft is one of nine devices chosen by the U.S. Food and Drug Administration to be part of a program to encourage early studies of innovative medical devices.
In the past, many of the first in-human studies of devices, such as hip and knee joints and stents that open blocked arteries, have been done outside the United States. This occurred because U.S. officials took a cautious approach, making sure that drugs and devices were safe and effective.
But that philosophy has changed in recent years, as patients and doctors urge the government to make new drugs and devices available. This trial of the branched stent graft is the first in many years to test a new device in U.S. subjects before it has been tested in patients elsewhere.
Arko, who helped design the device made by Medtronic, performed the studys first procedure April 11. He repaired an aortic aneurysm in a woman in her 80s. She did well and was discharged to her home five days later, CMC officials said.
Arko performed a second procedure at CMC April 17. Roselli did his first procedure in the study April 23.
Typically, this would go to Europe or Australia or Latin America, Arko said. The last patient that would have a chance to be treated with these devices would be patients in the United States. Now theyre trying to switch this around... to become more innovative while still being safe.
What is an aneurysm?
About 45,000 people die each year in the United States from aortic disease.
Its the 13th most common cause of death in men over 65, and has taken the lives of many celebrities, from John Ritter to Lucille Ball, and Albert Einstein to George C. Scott, Arko said.
But doctors believe aortic disease is underdiagnosed because many victims die suddenly when an unidentified aortic aneurysm bursts.
An aneurysm is a bulge in a weakened wall of the aorta, the largest artery in the body, which carries oxygen-rich blood from the heart to all parts of the body.
Standard treatment is open-chest surgery to repair the weakened area. A newer, less invasive procedure allows doctors to avoid making a large incision by placing the stent graft inside the aorta through thin tubes called catheters.
Supporting the aorta
Most stent grafts are fabric tubes supported by metal wire scaffolds that reinforce the weak spot in the aorta. The devices being studied by Arko and Roselli are not just straight tubes. They have two branches, which allows the doctors to repair aneurysms that occur near one of the large arteries that branch off the aorta.
The stent graft is delivered to the aorta through a catheter that is guided through blood vessels, starting from a small incision near the groin. When the catheter reaches the diseased portion of the aorta, it is withdrawn. The stent graft remains and expands like a spring to fit against the walls of the aorta on either side of the aneurysm. The graft allows blood to pass through without pushing on the aneurysm.
Today, aneurysms are often discovered incidentally when patients get imaging studies for other reasons.
Were getting much better at taking care of this disease, Roselli said. We dont have to wait until someone is in the emergency situation.
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